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NCT05070208Completed

Multicenter Retrospective Observatory of Patients With Acute Myeloid Leukemia to Core Binding Factor

Source: ClinicalTrials.gov · Last updated 2 Oct 2025

Brief summary (registry, in English)

Acute Core Binding Factor leukemias represent a specific category of acute myeloid leukemias that share prognostic factors, a specific mutational profile, and a favorable response to chemotherapy. Their management now follows the reference pattern from the French trial CBF-2006 closed to inclusions since November 2010. This includes intensive chemotherapy and intensification by allogeneic marrow transplant depending on the residual disease measured by RT qPCR . These leukemias have not been the subject of multicenter clinical trials since that date. The results of this treatment regimen need to be evaluated. Known prognostic factors such as signaling mutations, clonal interference or residual disease follow-up (MRD) will be analyzed and updated in this recent cohort. The interaction between residual disease and mutational profile will be evaluated on the prognosis. Treatment with gemtuzumab-ozogamycin and first-line allogeneic transplantation will be investigated, depending on prognostic factors including associated mutations and residual disease. The course and early treatment of molecular relapses will be analyzed. The treatment and prognosis of cytological relapses will be described with in particular the role of tyrosine kinase inhibitors and therapeutic intensification.

Status (registry)
Completed
Study type
Observational
Enrollment
400 (actual)
First submitted
27 Sept 2021
Start date
22 Sept 2021
Primary completion date
25 Jan 2024
Lead sponsor
Acute Leukemia French Association
NCT number
NCT05070208

What you commit to

  • Study type: Observational
  • Participants enrolled: 400
  • From 22 Sept 2021 to the primary completion date, 25 Jan 2024
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \- Opposition expressed to research

Who the study is looking for

  • Patients over 18 years old
  • Diagnosis of acute myeloid leukemia with CBF confirmed by cytogenetics (karyotype and / or FISH): t (8; 21), inv (16) or t (16; 16) and / or molecular biology (RUNX1-RUNX1T1 fusions or CBFB-MYH11)
  • Initial management by intensive chemotherapy, hypomethylants or targeted therapies

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
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AmiensFranceUnknown status
Centre Hospitalier Victor Dupouy
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ArgenteuilFranceUnknown status
AP-HP-GHU - Hôpital AVICENNE
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BobignyFranceUnknown status
CHU de la cote de Nacre
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CaenFranceUnknown status
CH Métropole-Savoie
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ChambéryFranceUnknown status
Hôpital Militaire Percy
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ClamartFranceUnknown status
Centre Hospitalier Sud Francilien
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Corbeil-EssonnesFranceUnknown status
Henri Mondor Aphp
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CréteilFranceUnknown status
Dijon Chu
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DijonFranceUnknown status
Centre Hospitalier de Dunkerque
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DunkirkFranceUnknown status
Centre Hospitalier de Versailles André Mignot
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Le ChesnayFranceUnknown status
LENS CHR
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LensFranceUnknown status
CHU
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LilleFranceUnknown status
Limoges - CHU
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LimogesFranceUnknown status
CHU La Conception
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MarseilleFranceUnknown status
CHU Nice,Hopital Archet 1
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NiceFranceUnknown status
Centre Antoine Lacassagne
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NiceFranceUnknown status
Hôpital Pitié-Salpêtrière - APHP
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ParisFranceUnknown status
Saint Antoine
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ParisFranceUnknown status
Hôpital Necker - APHP
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ParisFranceUnknown status
Hôpital Saint-Louis - APHP
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ParisFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
Centre Hospitalier Rene Dubos
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PontoiseFranceUnknown status
Centre hospitalier de Roubaix
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RoubaixFranceUnknown status
Centre Hospitalier de St Quentin
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Saint-QuentinFranceUnknown status
Institut Gustave Roussy
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VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.